August 18, 2008
As I see it
Another bad idea from government policy wonks surfaced in July when an FDA enforcement director told the Wall Street Journal his agency is using press releases as a vehicle for serving notice on certain companies that they are out of compliance with regulations, and to get their acts together.
David Elder told the WSJ that it was wrong to judge his agency's performance by the number of Warning Letters to industry it issues. These have been dwindling for years.
The FDA has other ways of bringing its enforcement concerns to industry's attention, he said. The newspaper quoted him as saying that rather than sending out individual Warning Letters to separate companies with a similar violation, the FDA now alerts the industry via press releases when it notices problems. Challenged later about the legal adequacy of a press release as a formal FDA warning, Elder referred us to the FDA Press Office, which issued a vaguely worded statement that press releases “can be an effective way to communicate to our various audiences our position or views and perhaps in some instances may help industry avoid regulatory action by understanding the FDA's position and how they can meet their regulatory obligations.”
While this might have been an example of the FDA not wanting to upset the WSJ by directly casting aspersions on the accuracy of the way it reported Elder, it equally might have been a way of back-pedaling on the whole strategy. With newspaper circulations tumbling throughout the nation, and TV news viewership in decline, this is no time for the FDA to be adopting a new policy of serving regulatory notice via news releases. There's no guarantee its releases will be published, much less reach target companies who could claim ignorance as an excuse. It makes you wonder how such ideas get off the ground.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)